Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates
Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates
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DOI：
10.1111/j.1365-2354.2010.01207.x
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发表时间：
2011-07-01
影响因子：
2.1
通讯作者：
Carlsson, C.
中科院分区：
文献类型：
--
作者：
Dellson, P.;Nilbert, M.;Carlsson, C.
临床试验对于改善癌症治疗至关重要，但招募却很困难。优化患者信息已被认为是一个关键问题。随着人们对医疗保健中患者观点的日益关注，我们旨在研究患者对三项乳腺癌临床试验中使用的书面信息的看法。主要数据收集是在与乳腺癌患者倡导者的焦点小组访谈中完成的。内容分析确定了三个主要主题：可理解性、情感和联想以及决策。根据倡导者提出的改进建议，通过独立的乳腺癌患者倡导者小组的问卷调查确定并验证了 21 个关键问题。清晰的信息、情绪中立的表达、对副作用的仔细描述、不同治疗方案之间的清晰比较以及有关停止治疗可能性的信息被认为是最重要的问题。患者对临床试验中信息的看法提供了新的见解，并确定了在优化未来书面信息时需要考虑的关键问题，并可能改善临床癌症试验的招募。
Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials.